FDA product code GPD: Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus
GPD is the FDA product code for antigen, indirect fluorescent antibody test, echinococcus granulosus. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel. Devices under GPD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus |
| Device class | Class I |
| Regulation | 21 CFR 866.3200 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GPD devices
openFDA lists no recalls for product code GPD.
Frequently asked questions
What is FDA product code GPD?
GPD is the FDA product code for antigen, indirect fluorescent antibody test, echinococcus granulosus. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel.
What device class is GPD?
Class I, regulation 21 CFR 866.3200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GPD
- Run a recall and safety report across every GPD manufacturer
- Watch product code GPD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.